EUCTR2004-000534-36-CZ进行中（未招募）1 期
Efficacy and Safety of Piascledine 300 versus Chondroitin Sulfate in a 6 Months Treatment plus 2 Months Observation in Patients with Osteoarthritis of the Knee
aboratoires Expanscience0 个研究点目标入组 300 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Female or male outpatients aged 45 years or more.
- •Patients complying with the clinical and radiological criteria of the American College of Rheumatology of knee osteoarthritis
- •·Duration of the disease longer than 6 months
- •·Pain and functional discomfort over 1 month during the last 3 months
- •·Pain on movement and/or pain at rest in the last 48 hours at least 40 mm evaluated on a VAS, and/or evaluate on at least 2 items among 5 items in the A-section of the WOMAC-index.
- •·No intake of analgesics for 48 hours
- •·No intake of NSAID for 5 days
- •·Lequesne index between 5 and 13 (moderate to very severe arthrosis)
- •·Radiological characterisation of stage I, II or III of the modified Kellgren and Lawrence classification scale on a frontal image of extended knee, on both knees , the image being not older than 6 months
- •·Patient capable of following the instructions of the study
- •·Signed informed consent following information provided by the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Known chondrocalcinosis of the joints
- •·Symptomatic femoro-patellar arthrosis
- •·Ochronosis or haemochromatosis
- •·Morbus Paget, Chondromatosis, Villo-nodular synovitis
- •·Haemophilia
- •. Septic arthritis
- •. Inflammatory joint disease
- •. Pseudo-gout
- •. Articulare farcture
- •. Acromegaia
- •. Wilson-disease
- •. Collagene gene mutations
- •·Osteoarthritis of the hip located at the site of the evaluated knee
- •·Osteoarthritis of the knee that may require surgical intervention during the planned duration of the study.
- •·Body-mass index >35
- •. Treatment with NSAID within 5 days or an analgesic within 48 hours before inclusion
- •·Treatment with SYSADOA within 3 months prior to inclusion
- •·Treatment with corticoids within one month prior to inclusion
- •·Intra-articular injection of corticoids, hyaluronic acid into the knee within 3 months prior to inclusion
- •·Treatment with pulsed electromagnetic field within 3 months prior to inclusion
- •·Synoviorthesis within 3 months prior to inclusion
- •·Operations (osteoctomy, meniscectomy) on the evaluated knee
- •·Diseases requiring the intermittent taking of corticoids (e.g. asthma)
- •. Patients with lipid metabolism disorders
- •. Patients who had already treatment with Piascledine® or Chondroitin-sulfate within the last 3 months
- •·Patients with serious evolutive heart condition, pulmonary, renal, hepatic, haematological, neoplastic or infectious diseases
- •·Patients with a known allergy to one of the components of the used drugs (test, comparative and/or rescue medication)
- •·Patients with leucopenia suffering from a serious hereditary disease
- •·Patients being pregnant or not having efficient contraception at the time of inclusion
- •·Patients having had an intricacy following an accident or net psychalgic component
- •·Patients already included in another therapeutic study
- •·Patients who already participated in a study in the month preceding the inclusion
- •·Patient incapable of keeping a self-assessment diary
- •Patient having femoro-tibial OA of the knee
研究者
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